USPTO Patents Application 10687850

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property Oi^anization
Internationa] Bureau

liiiiiiiiiiiiiiiiiiiiiiiiiiiiiiin

(43) International Publication Date (10) International Publication Number

27 February 2003 (27.02.2003) pCT WO 03/015627 A2

(51) International Patent Classification': A61B 5/00

(21) Internationa! Application Number: PCT/GB02/03772

(22) International Filing Date: 16 August 2002 (16.08.2002)*

(25) Filing Language: English

(26) Publication Language: English

(30) Priority Data:
60/313,059

16 August 2001 (16.08.2001) US

(71) Applicant (for all designated States except US): INVER-
NESS MEDICAL UMTIED [GB/GB]; Beechwood Park
North. Inverness, Scotland IV2 3EP (GB).

(72) Inventors; and

(75) Inventors/Applicants (for US only): MOERMAN, Piet
[BE/BE]; Ph. De Denterghemlaan 2. B-9831 St Maitens-
Latem (BE). GRmPITH, Alun [GB/GB]; 8 Culcabock
Road, Ijivemess IV2 3XQ (GB).

(74) Agents: MERCER, Christopher, Paul el al.; Caipmaels
& Ransford. 43 Bloomsbnry Square. London WCl A 2RA
(GB).

(81) Designated States (national): AE, AG, AL, AM, AT, AU,
AZ, BA, BB. BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU.
CZ, DE, DK, DM, DZ, EC, EE, ES, FX, GB, GD, GE, GH,
GM, HR, HU, ID, TL, IN, IS, JP, KE, KG, KP, KR, KZ, LC,
LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW,
MX, MZ, NO, NZ, OM, PH, PL, PT, RO. RU, SD, SE, SG,
SI, SK, SL, TJ, TM, TN, TR, TT, TZ, UA, UG. US, UZ.
VC, VN, YU, ZA, ZM, ZW.

(84) Designated States (regional): ARIPO patent (GH. GM,
KE. LS. MW, MZ. SD. SL, SZ, TZ, UG. ZM, ZW).
Eurasian patent (AM. AZ. BY, KG, KZ, MD, RU. TJ. TM),
European patent (AT, BE, BG, CH. CY. CZ, DE, DK, EE,
ES. FI. PR. GB, GR, IE. IT, LU, MC, NL, PT, SE, SK,
TR). OAPI patent (BF. BJ, CF, CG. CI, CM. GA, GN, GQ,
GW. ML. MR. NB, SN. TD. TG).

[Continued on next page]

= (54) Title: IN-SITU ADAPTER FOR A TESTING DEVICE

19

^ (57) Abstract: An adapter for a standard glucose meter to convert the glucose meter into an integrated testing device is provided.
S adapter comprises lancing device, a test strip port for holding a lest strip in close proximity to a puncture site, a strip connector
for providing an electrical connection between the test strip and the electronics in the glucose meter and a connector for connecting
Q the adapter to the glucose meter. The adapter further includes an adapter cap, including a pressure ring for facilitating the expression
of blood from a puncture site. The adapter includes a cocking mechanism for cocking the lancing device, a depth control mechanism
^ for varying the pcneUaiion depth of the lancet and a trigger for actuating the lancet.

wo 03/015627 A2 IlllliliillililPIIIiiiiiiiinilil

Published: fQf. two-letter codes and other abbreviations, refer to the "Guid-

— without Internationa! search report and to be republished ance Notes on Codes and Abbreviations " appearing at the begin-
upon receipt of that report . ning of each regular issue of the PCT Gazette.

wo 03/015627

PCT/GB02/03772

BV-SITU ADAPTER FOR A TESTING DEVICE
FIELD OF THE IPJTVENTION

5 The present invention relates to an adapter for a testing device for sampling

and analyzing analytes in bodily fluids, in particular a glucose meter for sampling and
analyzing glucose in blood or interstitial fluid.

BACKGROUND OF THE INVENTION

10

Glucose monitoring is a fact of everyday life for diabetic individuals. The
accuracy of such monitoring can significantiy affect the health and ultimately the
quality of life of a person with diabetes. Generally, a diabetic patient measures blood
glucose levels several times a day to monitor and control blood sugar levels. Failure
15 to test blood glucose levels accurately and on a regular basis can result in serious
diabetes-related complications, including cardiovascular disease, kidney disease,
nerve damage and blindness. A number of glucose meters are currently available
which permit an individual to test the glucose level in a small sample of blood.

20 Many of the glucose meter designs currently available make use of a

disposable test strip, which, in combination with the meter, electrochemically
measures the amount of glucose in the blood sample. To use these meters, the user
first pricks a finger or other body part using a separate lancing device to produce a
small sample of blood or interstitial fluid. The sample is then transferred to a

25 disposable test strip having an electrode system. The test strip is then inserted into the
glucose meter to measure the glucose level of the sample. The test strip may be
inserted into the meter prior to obtaining a blood sample. The inconvenience of
taking several measurements a day as well as the pain inflicted by currently available
lancets or finger-sticking devices often discourage disciplined and firequent testing.

30

While the fingertip is generally used for sampling blood, due to the rich
capillary bed of the skin of the fingertip, the fingertip is also particularly sensitive to
pain, due to a rich supply of pain receptors in the fingertip as well. When the incision
fi-om a lancet is too deep, too close to a recent incision or not deep enough and

. 1

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requires an additional incision, flie pain from a puncture is increased significantly.
Pain may also be increased if the cutting blade penetrates slowly or is withdrawn
slowly. Furthermore, the user may be forced to make a larger incision than is
necessaiy to form a sufficient amount of blood, due to losses incurred during the
5 transfer of the sample between the puncture site and the test strip.

The process of monitoring blood glucose levels requires several steps and
several different accessories, including a lancing device, a lancet, a supply of test
strips and a glucose meter. Each accessory has a different function. The user must

1 0 have a flat surface available to unpack and lay down the accessories within easy
reach. First, the user charges the lancing device with a fresh lancet. Then, the user
opens a vial of strips, removes a strip and inserts a strip into the meter. The user then
re-closes the vial and checks for the correct calibration code on the meter. Then the
user picks up the lancing device and lances the skm of the finger or other body part.

1 5 The user then lays down the lancing device and squeezes or massages the finger to
yield an adequate blood sample. The user then transfers the sample to a test strip for
analysis. Generally, a user is required to transfer a specific volume of sample to a
specific location on the small test strip, a difficult task for many users. After transfer
of the sample, the user waits for the meter to analyze the sample, then removes the

20 strip from the test meter and discards the strip, Fmally, the user re-packs all of the
accessories. As set forth above, the standard regime for monitoring glucose requires
the use of multiple, separate components.

The pain, inconvenience, cost, slowness, complexity and discreteness of
25 running a blood test are barriers to the frequent monitoring of glucose levels. Patients
often do not comply with doctor recommendations to frequently test glucose levels
due to the numerous obstacles involved.

30

SUMMARY OF THE INVENTION

In view of the foregoing and in accordance with one aq)ect of the present
invention, there is provided an adapter for a testing device for testing analytes in
bodily fluids comprising:

a housing;

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a lancet assembly comprising a lancet drive train for holding and driving a
lancet into tbe skin of a user;

a test port for holding a test strip; and

a housing connector for connecting the adapter housing to the testing device.

5

This way, a conventional testing device can be utilized and adapted with the
adapter to provide an integrated testing device which is more convenient to use,
thereby encouraging more frequent use of the testing device by a user.

10 The test strip is supplied to the adapter from a container separate to the

adapter. This has the advantage that the adapter, even when connected to the testing
device, is not bulky and is easy to use.

In one embodiment of the preset invention, the adapter further comprises:
15 a strip coimector for establishing electrical contact between a test strip in the

test port of the adapter and the testing device. Thus, strips held in the test port are
electrically coimected to the testing device.

Preferably, the adapter further comprises a removable lancet cap including a
20 pressure ring to assist extraction of a sample of bodily fluid.

Preferably, the adapter further comprises a dedicated storage compartment.
The dedicated storage compartment can store one or more additional lancets.

25 In one embodiment of the present invention, the adapter further comprises a

cocking button for cocking the lancet drive train.

Preferably, the adapter further comprises a trigger button for actuating the
lancet drive train.

30

Preferably, the adapter further comprises a depth adjustment button for
adjusting the penetration depth of the lancet. Thus, the penetration depth suitable for
obtaining a sample of bodily fluid from a particular individual can be optimized.

3

"^OOSmsCZl PCT/GB02/03772

Preferably, the angular position of the depth adjustment button defines a
cocked position and a final extended position of the lancet.

Preferably, the depth adjustment button includes a first slanted protrusion for
defining the cocked position and a second slanted protrusion that is parallel to the first
slanted protrusion for definmg the final extended position.

Preferably, the first slanted protrusion contacts a stop on the lancet drive train
to define the cocked position.

In one embodiment of the present invention, the adapter fiirther comprises a
cocking button for cocking the lancet drive train, wherein the second slanted
protrusion contacts a fixed cockmg rib on the cocking button.

Preferably, flie cocking button includes a stop for the lancet drive train, such
that the position of the cocking button defines the final extended position of the
lancet.

Preferably, the testing device is a glucose meter and the analyte being tested is
glucose in a sample of blood.

In accordance with a second aspect of the present invention, there is provided
a depth adjustment mechanism for a lancet device, comprising:

a substrate movably mounted in a slot of a housing of the lancet device and
having an interior surface;

a first projection on the interior surface of the substrate and defining an
interface with a lancet drive train; and

a second projection on the interior surface of the substrate substantially
parallel to the first projection and defining an interface with a cocking button.

Preferably, the position of the substrate in the slot defines a cocked position of
the lancet drive train and a stopping position of the lancet drive train.

WO 03/015627

PCT/GB02/03772

Preferably, the first projection interfaces with a catch on the lancet drive train
to dejBne the cocked position.

Preferably, the second projection interfaces with a stop for the lancet drive
5 train to define the stopping position.

Preferably, the stop for the lancet drive train comprises a cocking button for
the lancet drive train. ^

1 0 Preferably, the mechanism further comprises a rim disposed on the interior

side, wherein the rim interfaces with a groove on the housing to allow movement of
flie substrate.

Preferably, there is a knob disposed on an external surface of the substrate to
1 5 allow a usct of the lancet device to move the substrate in the slot

Advantageously, there is provided a cocking button for cocking the lancet
drive train and including a cocking rib for interfacing with the second projection and
an interior rib defining a stop for the lancet drive train.

20

PrefCTably, there is a catch on the lancet drive train for interfacing witii the
first projection to define a cocked position of the lancet drive train.

In accordance with a third aspect of the present invention, there is provided an
25 integrated testing device for testing analytes in bodily fluids comprising the
aforementioned depth adjustment mechanism.

In accordance with a fourth aspect of the present invention, there is provided
an integrated testing device for testing analytes in bodily fluids comprising:
30 ahousmg;

a lancet assembly comprising a lancet drive train for holding and driving a
lancet into the skin of a user,

a test port for holding a test strip;

5

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a testing device for testing analytes in bodily fluids applied to the test strip;
and

a housing connector for connecting the housing to the testing device.

5 In accordance with a fijfth aspect of the present invention, there is provided a

connector for connecting an adapter containing a lancing device to a testing device for
testing analytes in bodily fluids comprising:

a housing surface adapted to be removably mounted on the testing device; and
a projection on the housing surface,
10 wherein the projection is configured for connection with a housing feature on the
testing device, such that the connector connects the adapter to the testing device.

Preferably, the housing surface is a batteiy door and the housing feature is an
opening on the testing device.

15

In accordance with a sixth aspect of the present invention, there is provided a
method of providing an integrated testing device, comprismg:

providing a testing device for testing analytes in bodily fluids;
providing an adapter containing a housing, a lancet assembly, a test port for
20 holding a test strip, a strip connector for establishing electrical contact between a test
strip in the test port of the adapter and the testing device, and a housing connector for
. connecting the adapter housing to the testing device; and

attaching said adapter to said testing device using the housing coimector.

25 In accordance with a seventh aspect of the present invention, there is provided

a method of sampling and testing a sample of bodily fluid comprising:

providing a testmg device for testing analytes in bodily fluids;

providing an adapter containing a housing, a lancet assembly including a
lancet, a test port for holding a test strip, a test strip disposed in the test port, a strip
30 connector for establishing electrical contact between a test strip in the test port of tlie
adapter and the testing device, and a housing connector for connecting the adapter
housing to the testing device;

attaching the adapter to the testing device using the housing connector to form
an integrated device;

6

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cockiiig the lancet assembly; and

actuating the lancet assembly to drive the lancet into the skin a predetennined
. depth to produce a blood sample, wherein the test strip absorbs the sample and
produces a signal indicative of an analyte level and wherein the strip connector
automatically transmits the signal indicative of the analyte level to the testing device.

In an illustrative embodiment, the present invention provides a clip-on adapter
device for a standard glucose meter to convert the meter into an integrated single-unit
testing device. The adapter comprises a lancing device, a test strip port for holding a
test strip in close proximity to a puncture site, a strip connector for providing an
electrical connection between the test strip and the electronics in the glucose meter
and a connector for connecting the adapter to the glucose meter. The adapter further
includes an adapter cap, including a pressure ring for facilitating the expression of
blood from a puncture site. The adapter includes a cocking mechanism for cocking
the lancing device, a depth control mechanism for varying the penetration depth of the
lancet and a trigger for actuating the lancet

According to the illustrative embodiment, the depth control mechanism
comprises an arc-shaped substrate and two ribs disposed on the interior of the
substrate. The ribs define the starting position and the stopping position of the lancet.
A first rib interfaces with a stop on the lancet barrel to define the starting position of
the lancet when the lancet is cocked. The second rib interfaces with a cocking rib on
the cocking button to define the position of a stop located on the cocking button
corresponding to the extended position of the lancet. The depth control mechanism is
rotatably mounted on the adapter housing such that a Icnob of the depth control
mechanism protrudes fi-om the housing. A user rotates the depth control mechanism
about the longitudinal axis of the adapter to vary the position of the two rib interfaces,
and thus vary the penetration depth of the lancet.

The adapter of the present invention achieves in situ testing by converting a
standard glucose meter into an integrated blood sampling and testing device. The user
can attach the adapter to the glucose meter to integrate the process of obtaining a
blood sample and testing the components of the blood sample. The use of the^clip-on
adapter with a standard glucose meter eliminates the need to transfer a blood sample

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from a sampling site to a test strip and the need to then transfer the test strip to a
separate glucose meter. The adapter combmes the separate accessories involved in
glucose monitoring into a single, easy-to-use and conv^ent device. The adapter can
also be detached from the glucose meter and used separately, if so desired.

5

BRIEF DESCWPTION OF THE DRAWINGS

These and other features and advantages of the present invention will be more
fully understood by reference to the following detailed description in conjunction with
10 the attached drawmgs in which like reference numerals refer to like elements through
the different views.

A specific embodiment is now described by way of example only and with
reference to the accompanying drawings, in which:

15

Figure 1 is a general view of the adapter of the illustrative embodiment of the
invention attached to a standard glucose meter;

Figure 2 is a side view of the adapter and glucose meter assembly of Figure 1;
Figure 3 is a general view of the adapter and glucose meter assembly of Figure

20 1;

Figure 4 illustrates the adapter wherein a half of the housing and the cap are
removed to expose the interior of the adapter;

Figure 5 is an exploded view of the lancing mechanism in the device;

Figure 6 illustrates the lancet barrel of the adapter;
25 Figures 7a and 7b illustrative the details of the depth adjustment button;

Figure 8 illustrates the lancing mechanism in a cocked position the cocking
button removed for clarity;

Figures 9a and 9b illustrate the details of the cocking button of the adapter;

Figure 1 0 illustrates the assembled lancing mechanism during a cocking
30 process;

Figure 1 1 is a general partial view of the adapter, illustrating the connector for
connecting the adapter to a glucose meter; and

8

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Figures 12a, 12b, 12c and 12d illustrate the strip contact extension feature for
extending electrical contact jfrora a test strip in the adapter to the glucose meter
electronics.

5 DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENT

The present invention is described below relative to an illustrative
embodiment. Those skilled in the art will appreciate that the present invention may be
implemented in a number of different applications and embodiments and is not
10 specifically limited in its application to the particular embodiment depicted herein.
The present invention is discussed below in connection with sampling blood for
analysis by a glucose meter, although those of ordmary skill will recognize that oihsr
types of testing devices could be used for sampling and testing other fluids,

15 There is now described an illustrative embodiment of an adapter according to

the present invention. The adapter is for use with a glucose meter to provide an
integrated device for obtaining and analyzing a sample of bodily fluid, such as blood.
The adapter facilitates the monitoring of blood glucose levels by providing a means
for integrating into a single device the steps involved in sampling and analyzing

20 blood. The integration results in a simplified process employing a single device.

Figure 1 illustrates a clip-on adapter device 10 of the illustrative embodiment
of the present invention. The adapter device 10 is attached to a standard glucose
meter 1 1 to convert the glucose meter into an integrated device for sampling and

25 testing a blood sample. The adapter device 10 includes a housing 12, a lancing

mechanism (not shovm), including a lancet for pxmcturing the skin of a user to express
a drop of blood, a cocking button 1 3 for cocking the lancing mechanism and a depth
adjustment button 1 8 for adjusting the penetration depth of the lancet. As shown, the
cocking button 13 is slidably mounted in the housing and protrudes through

30 longitudinal slot in the housing. According to the illustrative embodiment, a user
retracts the cocking button towards the distal end of the housing to cock the lancing
mechanism. The depth adjustment button 1 8 is rotatably mounted in the housmg and
protrudes through a second longitudinal slot in the housing. The user rotates the depth
adjustment button 18 about its axis to vary the penetration depth of the lancet. After

9

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the user cocks the lancing mechanism and selects a penetration depth, the user
depresses a triggering button 23 to release the lancet from the cocked position. A
housing connector 17 connects the adapter 10 to the glucose meter 1 1 to form an
integrated sampling and testing device. According to the illustrative embodiment, the
5 housing connector 1 7 replaces the original battery door of the glucose meter and has
the dual function of enclosing a battery compartment in the glucose meter and
providing a connection to the adapter 10.

A removable lancet cap 14 is attached to the proximal end of the housing and
1 0 mcludes an aperture 1 9 to allow passage of the lancet through the cap and into the.
skin of the user. According to the illustrative embodiment, the cap is substantially
clear or includes a substantially clear portion to allow a user to view a sample being
expressed from the puncture site when the lancet punctures the skin of the us©:. The
cap 14 includes a pressure ring 16 disposed about the aperture 19. The pressure ring
15 16 has a multi-contoured surface in order to promote, enhance or facilitate the

expression of blood by pressing the device onto the skin. A hinged door 15 provides
access to the interior of the cap 14. According to the illustrative embodiment, a
storage compartment (not shown) is provided within the interior of the cap 14, which
allows a user to store spare lancets, pressure rings, test strips and the like.

20

The cap 14 for the adapter includes a pressure ring 16 attached to the distal
end of the cap body. As discussed, the pressure ring 16 is mounted around and
encloses the aperture 19 through which the lancet passes. The pressure ring 16 has a
multi-contoured surface oriented generally about an axis distinct from the axis of

25 motion of the lancet. The multi-contoured surface is designed to exert pressure on the
dermal tissue to facilitate expression of a fluid sample after lancing the dermal tissue.
According to an alternate embodiment, the pressure ring 16 comprises a pair of
pressure wings sized and dimensioned to accommodate the sharp curve of the
fingertip therebetween. The pressure wings thus form a recess for accommodating the

30 finger of the user. This apphes the correct amount of pressure to allow for the
expression of blood.

A test strip 20 is positioned in an aperture 19 or a test port (not shown) and
extends through the aperture 19. When the lancet punctures the skin and a drop of

10

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» blood forms on the skin surface, the position of the test port locates the test strip in
close proximity to receive the blood sample. The adapter further includes an
extension (not shown) to the test port of the glucose meter 1 1, which extends the
electrical contacts from the test port of the glucose meter to the contacts on the test
5 strip 20. In this manner, in situ testing of the blood sample is enabled. The individual
features and components of the adapter device 10 will be described in more detail
below.

The adapter device 10 of the illustrative embodiment is configured to clip onto
10 a standard glucose meter, such as a One Touch Ultra meter from Lifescan, the QID
meter from Abbott, the Glucometer Elite meter from Bayer, the Advantage meter
from Roche, and other commercially available glucose meters. The housing
connector 17, which enables the attachable clip-on feature, may be customized for any
suitable particular glucose meter employed by the user.

15

Figure 2 illustrates a side view of the adapter device 10 connected to the
glucose meter 1 1 and including an alternative access port 21, As illustrated, the
alternative access port 21 is provided in the hinged door 15. The alternative access
port 21 accepts an alternative test strip such that contacts on the alternative test strip

20 connect to the electrical contacts from the test strip port. The alternative access port
21 does not have a sunx)unding pressure ring 16 or lancet adjacent the alternative
access port 2 1 . This way, a test strip can be placed in the alternative access port 2 1 ,
the skin of a user can be pricked with an independent lancing device to obtain a blood
• sample, and the blood sample can be applied to the test strip for analysis by the

25 glucose meter 11.

Figure 3 is a general view of the integrated device comprising the adapter 10
connected to the glucose meter 1 1 . In Figure 3, the cocking button 1 3 is shown in a
retracted position, corresponding to the end of a cocking process. The depth
adjustment button 1 8 shown in Figure 3 is rotated to select a minimimi puncture

30 depth. As discussed, the puncture depth is determined by the position of the depth
adjustment button, and the puncture depth is adjusted by rotating the button between a
variety of positions. According to the illustrative embodiment, the depth adjustment
button is rotated to the left side of the longitudinal slot to select a minimum depth and
the right side of the longitudinal slot to select a maximum penetration depth. One

11

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skilled in the art will recognize that the depth adjustment feature is not limited to the
illustrative embodiment. For example, the depth adjustment button 1 8 may be
configured such that rotation to the right will decrease the penetration depth.
Alternatively, the depth adjustment button may be configured such that a linear
movement in a predetermined direction alters the penetration depfli of the lancet.

Figure 4 illustrates the adapter 10 wherein a half of the housing 12 and the cap
14 are removed to expose the interior of the adapter 10. The interior of the adapter
houses the lancing mechanism 25, a test strip 20, a set of electrical contact bars 26 and
a printed circuit board 27 for connecting the test strip to the glucose meter. The
lancing mechanism is slidably mounted within the housmg of the adapter 10 and
includes a disposable lancet 28 and a lancet drive train for driving the lancet into and
out of the skin of a user. The lancet drive train comprises a lancet barrel 29 having a
barrel coUar 36 and a barrel base 33, a first spring 30, a second spring 3 1 and a spring
retainer 32. The lancet 28 is releasably mounted in the proximal end 29a of the lancet
barrel 29. The lancet barrel is connected to the cocking button (not shown in Figure
4), such that retraction of the cockmg button towards the distal end of the adapter will
retract the lancet barrel to a cocked position. In addition, Figure 4 illustrates the
implementation of storage compartments within the housing of the adapter 10 for
storing a spare lancet 28a and a spare or altemate pressure ring 16a.

The first spring 30 comprises a relatively strong spring for driving the lancet.
The first spring 30 is housed between tiie barrel collar 36 and the spring retainer 32
and is compressed when the lancing mechanism is retracted to the cocked position.
According to the illustrative embodiment, the amount of compression in the first
spring 30 when the lancet is fully cocked depends on tiie position of the depth
selection button, which will be described in detail below! The first spring 30 has a
restoring force that is proportional to the amount of compression. When flie lancet
barrel is released from the cocked position by depressing the trigger button, the
restoring force propels the lancet along a predetermined path through the aperture 19
of the adapter. The second spring 31 comprises a relatively weak spring and is
housed between an interior rib of the cocking button (not shown in Figure 4) and the
ban-el base 33. The weak spring 31 is also compressed as the cocking button is
retracted to cock the lancet. When the user releases the cocking button, the weak

12

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spring biases the cocking button back to a rest position, while the lancet bairel
remains in a locked cocked position.

Figure 5 is an exploded view of the lancing mechanism 25, illustrating the
different components and the relative positions of the respective components involved
in the lancing and depth adjustment functions. The trigger button 23, depth
adjustment button 18 and the cocking button 13 are arranged relative to each other
and the lancet barrel 29 and cooperate to arm the lancing mechanism, fire the lancing
mechanism and control the penetration depth of the lancet. As discussed, the cocking
button 13 operates to retract the lancet barrel 29 from a rest position to a cocked
position. The barrel is temporarily locked in the cocked position by a rib 41 located
on the interior side of the depth adjustment button 1 8. The position of the depth
adjustment button 1 8 determines the starting position (i.e. the cocked position) of the
lancet 28 before the lancet is released and penetrates the skin. The trigger button 23
releases the barrel 29 from the cocked position when a user depresses the trigger
button. Upon release, the lancet travels a predetemuned distance until the barrel base
33 abuts an intemal rib 47 of the cocking button, which stops the lancet travel. The
first spring 30 then retracts the lancet from the skin. The working and functionality of
the different components, particularly the lancet barrel 29, the cocking button 13, the
depth adjustment button 18 and the trigger button 23 will be described in detail below.

Figure 6 illustrates the lancet barrel 29 of the adapter 10 according to the
illustrative embodiment. The proximal end 29a of the lancet barrel is configured to
hold a lancet 28. The barrel 29 mcludes a flexible arm 34 and a catch 35 on the
flexible arm for temporarily locking the barrel 29 in a cocked position. According to
the illustrative embodiment, the catch 35 interfaces with a rib 41 on the depth
adjustment button, shown in Figure 7 and described in detail below, to lock the barrel
in the cocked position. According to the illustrative embodiment, the position of the
cocked lancing mechanism is determined by the angular position of the depth
adjustment button 1 8. The trigger button 23 cooperates with an end portion 37 of the
flexible arm 34 to release the barrel 29 from the cocked position. When a user
depressed the trigger button 23, the trigger presses the end portion 37, which forces
the flexible arm 34 to flex, thereby releasing the catch 35 from the rib of the depth
adjustment button 18.

13

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PCT/GB02/03772

Figures 7a and 7b illustrate the depth adjustment button 18 according to the
illustrative embodiment. The depth adjustment button 18 allows a user to select a
preferred penetration depth and customize the adapter to diflferent people and different
body parts. The depth adjustment button 1 8 comprises an arc-shaped substrate that is
rotatably mounted in the housing 12 of the adapter and extends through a longitudinal
slot in the housing 12, as illustrated in Figures 1-3. A knob 40 disposed on the
exterior side of the depth adjustment button 18 may be grasped by a user to rotate the
depth adjustment button about the longitudinal axis of the adapter 10 to select the
desired penetration depth. A rim 44 on the depth adjustment button 18 cooperates
with a groove in the housing to facilitate rotational- movement of the depth adjustment
button. The angular position of the depth adjustment button 18 detemiines the depth
of the lancing mechanism. To increase the penetration depth, a user rotates the depth
adjustment button in a first direction. To decrease the penetration depth, the user
rotates the depth adjustment button in an opposite direction.

To provide the variable depth feature, a first rib 41 and a second rib 42 are
disposed on an interior side of the depth adjustment button 18. According to the
illustrative embodiment, the ribs 41 and 42 are slanted to allow selection of variable
penetration depths, to provide smooth transition between different positions, and to
accommodate the limited space underneath the surface of the depth adjustment button
18. The first rib 41 cooperates with the catch 35 on the flexible arm of the lancet
barrel to define a cocked position of the lancet, as described above. As shown, the
longitudinal position of any segment of the first rib 41 is controlled by the rotation of
the button around its axis. The second rib 42 is parallel to the first rib and interfaces
with a cocking rib 46 on the cocking button 13, to be described in detail below, to
define the final penetration depth of the lancet. The cocking rib 46 on the cocking
button 13 abuts the second rib 42 to define the rest position of the cocking button 13.
The cocking button in turn defines a stop for the lancet mechanism, thereby
controlling the penetration depth of the lancet 28. (The position of the depth
adjustment button defines the position of the cocking button, which defines the stop
position of the lancet). The rotation of the depth adjustment button 1 8 brings different
portions of tiie ribs 41, 42 into the path of the catch of the lancet barrel 29 and tiie
cocking rib of the cocking button 1 3 , respectively. Wlien rotated to the left, the rib

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interfaces (i.e. the starting and stopping positions of the lancet) are moved back
towards the distal end of the adapter, decreasing tlie amount that the lancet protrudes
from the aperture. When rotated to the right, the rib interfaces move forwards,
towards the proximal end of the adapter, thereby increasing the amount that the lancet
5 protrudes from the aperture. A depth selection arm 43 allows a user to select a
discrete depth position when rotating the depth adjustment button 18 about its axis.
The arm 43 "clicks" into each discrete depth position to indicate to the user that a
particular depth has been selected. The depth adjustment feature provides a simplified
and accurate means for ensuring that a desired penetration depth is achieved. One
10 skilled in the art will recognize that the depth adjustment button is not limited to the
illustrative configuration and that any suitable shape or airangement may be utilized
to select a penetration depth for a lancet and that the present invention is not limited to
the illustrative embodiment

15 Figure 8 illustrates the lancing mechanism in a cocked position. As shown,

the depth adjustment button 1 8 holds the lancing mechanism in the cocked position.
As the lancing mechanism, including the barrel 29, is retracted using the cocking
button, the catch 35 of the barrel 29 is caught behind the first rib 41 of the depth
adjustment button to temporarily lock the barrel in the cocked position. As shown,

20 the position of the depth adjustment button 18 defines the starting position of the
lancet, and rotation of the dq)th adjustment button varies the starting position of the
lancet. In Figure 8, the depth adjustment button 18 is rotated to the left to move the
starting position back towards the distal end of the adapter and thereby produce a
shorter penetration depth. As discussed, the trigger 23 is depressed to flex the flexible

25 arm 34 and release the lancet barrel catch from behind the first rib 41 .

Figures 9a and 9b illustrate the cocking button 13 of the illustrative
embodiment. As discussed, the cocking button 13 is slidably mounted in the housing
12 of the adapter 10 of the illustrative embodiment and extends through a longitudinal
30 slot in the housing. The cocking button 13 of the illustrative embodiment comprises a
substrate 13a, a cocking knob 45 and a cocking rib 46 disposed on the exterior surface
of the substrate 13a and an interior rib 47 disposed on the interior surface of the
substrate 13a. The cocking button 13 is connected to the lancing mechanism 25 and
adapted to sHde in the longitudinal slot.

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, PCT/GB02/03772

Figure 10 illustrates the assembled lancing mechanism, including fee cocking
button, the trigger button and the depth adjustment button during the cockmg process.
To cock the lancing mechanism, a user grasps the cocking knob 45 and slides the
cocking button 1 3 towards the distal end of the adapter 1 0. The interior rib 47 on the
cocking button 13 abuts the bane! base 33 and forces the bairel base 33 to retract with
the cocking button. During the cocking process, the weak spring 31 becomes
compressed betwem the interior rib 47 and the barrel base 33. The strong spring 30
becomes compressed between the barrel collar 36 and the spring retain» 32. The first
rib of the depth adjustment button 1 8 c^tures the catch 35 of the lancet barrel 29 to
hold the lancing mechanism in the cocked position, such that the strong spring
remains compressed 30. The weak spring 3 1 of the lancing mechanism biases the
cocking button back towards the proximal end of flie adapter, nntil the cocking rib 46
on the exterior surface of the cocking button 13 abuts flie second rib on the interior of
the depth adjustment button 1 8. The interface between the cocking rib 46 and flie
cocking button 13 defines the rest position of the cocking button 13. The interior rib
47 of tlie cocking button includes an opening sized and dimensioned to allow the
lancet barrel 29 to slide through while retaining the barrel base 33. The mterior rib 47
serves as a stop for the lancet. When the drive train drives the lancet 28 through the
aperture 1 9 in the adapter cap 14, the interior rib 47 stops lancet at a predetennined
travel depth. As discussed, the position of the interior rib 47, and thus the penetration
depth of the lancet, is defined by the position where the cocking rib 46 strikes the
second slanted rib 42 of the depth adjustment button 1 8, which is in turn defined by
the axial position of the depth adjustment button 18.

The lancing mechanism of the illustrative embodiment, including the system
and method for adjusting the penetration depth, may be used alone, and is not limited
to use in an adapter for a glucose meter, as illustrated. According to an alternate
embodiment of the invention, the illustrated lancing mechanism may be utiUzed in a
stand-alone lancet device that is not adapted to attach to a glucose meter, which
incorporates tlie depth adjustment capabilities described herein.

Figure 1 1 is a general partial view of the adapter 10 of tlie present invention
connected to a glucose meter 1 1. Figure 1 1 illustrates the attachment of the adapter

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10 to the glucose meter using a housing connector 17 specially designed to integrate
the adapter device with the meter. According to the illustrative embodiment, the
housing connector 17 is configured to replace the original battery door of the meter.
The housing connector 17 rephcates the battery door and covers the batteries (not
5 shown) in the glucose meter in the same way. The housing connector 1 7 further

includes protrusions 17a and 17b, which are configured to secure the .adapter 10 to the
glucose meter 1 1. As shown, the adapter 10 includes slots 50a, 50b for receiving the
protrusions 17a, 17b, One skilled in the art will recognize that any suitable means for
releasably attaching the adapter device 10 to a glucose meter may be utilized.

The adapter fiirther includes a strip contact extension for facilitating in situ
electrochemical analysis of the sample by connecting the test strip inserted into a test
port to the attached glucose meter. The strip contact extension feature is illustrated in
detail in Figures 12a, 12b, 12c and 12d. The strip connector 51 establishes electrical
contact between the original test port of the glucose meter and the test strip 20 in the
adapter. The electrical contact bars 26 on the strip connector contact electrodes
formed on the test strip 20. The electrical contacts are connected to a printed circuit
board 27 which contacts the original contacts (not shovm) of the glucose meter. A
substrate, comprising two parts 52a and 52b are used to assemble the electrical
contact bars 26 and printed circuit board 27. The strip connector 51 is connected to
the adapter such that the printed circuit board will contact the original contacts of the
glucose meter when the adapter is attached to the glucose meter. The original
contacts of the glucose meter connect to electronics located within the glucose meter
housing. The test strip generates electrochemical signals that are passed by the strip
connector to the glucose meter electronics. As known in the art, the electronics in the
glucose meter process the signal and calculate the glucose level or other
electrochemically detectable analyte of the blood or other interstitial fluid that is
sampled by the testing device. The electronics transmit instructions for an appropriate
display or output regarding the analysis.

The test strip 20 essentially comprises an electrochemical cell, includmg one
or more working electrodes, which convert a chemical change produced by a reaction
of glucose or other analyte in the blood sample to a current. The test strip 20 further
includes a reference electrode as a standard to measure the potential of the working

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electrodes. Leads connect the electrodes to the contact bars 26 of the strip connector
51, which establishes electrical contact with the electronics of the glucose meter. The
test strip thus generates a signal indicative of the level of glucose or other analyte in
the blood and transmits this signal to the electronics of the device for processing.
5 Those skilled in the art will recognize that a variety of test strip designs and

configurations are available in accordance with the teachings of the present invention.

The illustrative embodiment of the invention achieves in situ testing of a blood
sample based on proximity to a lancet wound. When the lancet 28 punctures the skin,

10 a drop of blood forms on the skin surface. The test strip 20 is moved into close
proximity to the puncture wound to ensure that blood contacts the strip. Moreover,
the positioning of the test strip adjacent the lancet ensures that only small volumes of
blood are required. According to the present mvention, the test strip is separated fi-om
or positioned relative to the deployed lancet or lancing site between about 0.4 mm and

15 about 1.3 mm, and preferably between about 0.7 mm and about 0.9 mm. Once the
drop grows to a certain size, the drop touches the entrance of the capillary channel and
is consequently drawn into the strip for analysis. The test strip wicks the blood
sample directly from the puncture wound, allowing low volume blood samples for
analysis. The test strip is positioned to automatically and efSciently direct the sample

20 to a defined area of the test strip for analysis. The described arrangement efficiently
conveys a sample from the skin to a precise position on the test strip witli little to no
losses. Furthermore, the established electrical connection between the test strip 20
and the glucose meter electronics, provided by the strip connector 51 of the adapter
10, allows analysis of the sample to occur without necessitatmg transfer of the sample
25 or the test strip.

To measure blood glucose levels, a user first attaches the adapter 10 to the
glucose meter 1 1 to provide an integrated sampling and testing device. The user
inserts at test strip 20 into the test port, such that the test strip is in close proximity to
30 the puncture site. The user cocks the lancing drive train by pulling back the cocking
button 13, and subsequently releases the cocking button, which automatically returns
to a rest position. The user selects a suitable penetration depth by rotating the depth
adjustment button 1 8, the angular position of which defines the starting and stopping
position of the lancet 28. The user then presses tlie adapter against a body part, such

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as a finger, such that the skin of the user contacts the pressure tip 16. The user
depresses the trigger button 23 to release the lock on the lancet barrel 29 formed by
the interface between the first rib 4.1 of the depth adjustment button 1 8 and the
flexible arm 34 of the barrel. Consequently, the restoring force in the strong spring 30
5 drives the lancet tip 28 a predetermined depth into the skin, in close proximity to the
test strip 20. The barrel base 33 abuts the interior rib 47 of the cocking button 13 to
stop the lancet at the predetermined depth. The lancet assembly immediately retracts
the lancet fi-om the skin, yielding a drop of blood or other bodily fluid on the skin
surface. According to one practice of the invention, the pressure tip 16 in the adapter

10 cap 14 squeezes the skin to maximize the quantity of blood formed from a puncture.
As the blood drop grows, the blood contacts a channel entry of the proximally located
test strip 20, which absorbs the blood sample and directs the blood sample to an
analysis portion. The analysis portion of the test strip generates a signal indicative of
glucose levels, which is automatically provided to the glucose meter via the strip

1 5 connector 5 1 . In situ testing of the blood sample is enabled by virtue of the location
of the adapter and test strip. In other words, the adapter allows the blood sample to be
tested without necessitating manual transfer of the sample from the puncture site to
the glucose meter. The glucose meter 1 1 displays and stores the glucose reading.
After the analysis is complete, the user removes the adapter cap 14 and the lancet 28

20 firom the lancet barrel 29. The user may then discard the lancet, if desired.

The illustrative embodiment of the invention provides significant advantages
to testing and sampling blood by providing a device for integrating the sampling and
testing of blood into a single, user-friendly device. The adapter can be retrofitted to
25 an existing glucose meter to convert the glucose meter to have sampling capabilities.
The adapter can also be detached and used separately from the glucose meter, if
desired. The adapter encourages frequent use by reducing the pain, inconvenience
. and complexity of performing a blood test. The adapter reduces the number of
accessories and steps by integrating all of the different accessories involved in glucose
30 monitoring into one unit. The dedicated storage space provided in the adapter cap
allows a user to store spare lancets, test strips and pressure tips conveniently and
. within easy reach. The invention fiirther improves the efficiency and accuracy of
testing by providing an automated transfer and analysis of the sample. The use of the
clip-on adapter with a standard glucose meter eliminates the need to transfer a blood

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sample from a sampling site to a test strip and the need to then transfer the test strip to
a separate glucose meter. The mtegrated testing device enabled by the adapter is
compact, ergonomically soimd, discrete and adjustable to different users and body
parts while simultaneously providing fast and accurate results.

The present invention achieves pain-free testing in a number of ways.
Shallower penetrations of the skin can be used to achieve a suflBcient blood sample,
reducing painful deep incisions in sensitive body parts. The present invention
requires low sample volumes for analysis. The finger squeezing mechanism formed
by the pressure tip on the lancet cap provides a high yield for small puncture wounds.
The integrated sampling and testing feature further ensures full usage of the obtained
sample and limits "leftovers" on the skin. In current systems, complex and inaccurate
sample transfer from a sampling point to an application area on a test strip requires
suiplus sample due to poor utilization of an obtained sample drop. The present
invention removes the inefficiency of transferring samples and provides optimal
utilization of the obtained sample by automatically directing the sample to a precise
location on the test strip. The superficial penetrations reduce agitation of nerve
endings in the skin and reduce pain in sensitive body areas.

The variable depth of the lancet and the ability to test on a number of different
body parts in addition to the fmger reduces the concentration and repetition of micro-
traumata in a small area, which result in tinting, itching, dried and callous skin areas.
The illustrated depth adjustment mechanism, whether implemented in the adapter
device or in a standard lancing device, provides a user-friendly means for precisely
controlling the penetration depth of the lancet.

The present invention further provides easy and uncomplicated operation. The
sampling and testing device significantly reduces the time and difficulty involved in
sampling and testing blood. The adapter is designed such that one-handed operation
is possible, eliminating the need for a separate workspace. The fully automated
testing system is not subject to human error and inefficiency. The present invention
also reduces waste by efficiently utilizing available resources. The present invention
further protects against compromised test results due to contamination or an
improperiy calibrated glucose meter.

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PCT/GB02/03772

In conclusion, the integrated sampling and testing device of the present
invention significantly reduces the obstacles associated with frequent glucose
monitoring. The present invention promotes frequent monitoring for diabetic
individuals by providing a simple, efficient, fast and accurate integrated sampling and
testing device.

Since certain changes may be made in the above constructions without
departing fi-om the scope of the invention, it is intended that all matter contained in
the above description or shown in the accompanying drawings be interpreted as
illustrative and not in a limiting sense.

It is also to be understood that the following claims are to cover all generic and
specific features of the invention described herein, and all statements of the scope of
the invention which, as a matter of language, might be said to fall therebetween.

In addition, it will of course be understood that the present invention has been
described above purely by way of example and modifications of detail can be made
within the scope of the invention.

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CLAIMS

PCT/GB02/03772

1. An adapter for a testing device for testing analytes in bodily fluids comprising:
a housing;

5 a lancet assembly comprising a lancet drive train for holding and driving a

lancet into the skin of a user;

a test port for holding a test strip; and

a housing connector for connecting the adapter housing to the testing device.

10 2. The adapter of claim 1 , further comprising:

a strip connector for establishing electrical contact between a test strip in the
test port of the adapter and the testing device.

3. The adapter of claim 1 or claim 2, further comprising a removable lancet cap
1 5 including a pressure ring to assist extraction of the blood sample.

4. The adapter of claim 3, further comprising a dedicated storage compartment

5. The adapter of any one of claims 1 to 4, further comprising a cocking button
20 for cocking the lancet drive train.

6. The adapter of any one of claims 1 to 5, further comprising a trigger button for
actuating the lancet drive train,

25 7. The adapter of any one of claims 1 to 6, further comprising a depth adjustment
button for adjusting a penetration depth of the lancet.

8. The adapter of claim 7, wherein the angular position of the depth adjustment
button defines a cocked position and a final extended position of the lancet.

30

9. The adapter of claim 8, wherein the depth adjustment button includes a first
slanted protrusion for defining the cocked position and a second slanted protrusion
that is parallel to the first slanted protrusion for defining the final extended position.

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10. The adapter of claim 9, wherein the first slanted protrusion contacts a stop on
the lancet drive train to define a cocked position.

11. The adapter of claim 9 or claim 10, further comprising a cocking button for
5 cocking the lancet drive train, wherein the second slanted protrusion contacts a fixed

cockmg rib on the cocking button.

12. The adapter of claim 1 1, wherein the cocking button includes a stop for the
lancet drive train, such that the position of the cocking button defines the final

1 0 extended position of the lancet.

13. The adapter of any one of the preceding claims, wherein the testing device is a
glucose meter and the analyte being tested is glucose in a sample of blood.

15 14. A depth adjustment mechanism for a lancet device, comprising:

a substrate movably mounted in a slot of a housing of the lancet device and
having an interior surface;

a first projection on the interior surface of the substrate and defining an
interface with a lancet drive train; and
20 a second projection on the interior surface of the substrate substantially

parallel to the first projection and defining an interface with a cocking button.

15. The depth adjustment mechanism of claim 14, wherein the position of the
substrate in the slot defines a cocked position of the lancet drive train and a stopping '

25 position of the lancet drive train.

16. The depth adjustment mechanism of claim 15, wherein the first projection
interfaces with a catch on the lancet drive train to define the cocked positioa

30 17. The deptli adjustment mechanism of claim 15 or claim 16, wherein the second
projection interfaces with a stop for the lancet drive train to define the stopping
position.

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WO03/015()27 PCT/GB02/03772

1 8. The depth adjustment mechanism of claim 1 7, wherein the stop for the lancet
drive train comprises a cocking button for the lancet drive train.

1 9. The depth adjustment mechanism of claim 1 8, fiirther comprising a rim
disposed on the interior side, wherein the rim interfaces with a groove on the housing
to allow movement of the substrate.

20. The depth adjustment mechanism of any one of claims 14 to 19, further
comprising a knob disposed on an external surface of the substrate to allow a user of
the lancet device to move the substrate in the slot

21. The d^th adjustment mechanism of any one of claims 14 to 20, fturther
comprising a cocking button for cocking the lancet drive train and including a cockmg
rib for interfacing with the second projection and an interior rib delSning a stop for
lancet drive train,

22. The dqpth adjustment mechanism of claim 2 1 , further comprising a catch on
the lancet drive train for interfacing with the first projection to define a cocked
position of the lancet drive train.

23. An integrated testing device for testing analytes in bodily fluids comprising
the depth adjustment mechanism according to any one of claims 14 to 22.

24. An integrated testmg device for testing analytes in bodily fluids comprising:
a housing;

a lancet assembly comprising a lancet drive train for holding and driving a
lancet into the skin of a user;

a test port for holding a test strip;

a testing device for testing analytes in bodily fluids applied to the test strip;
and

a housing connector for connecting the housing to the testing device.

25. A coimector for connecting an adapter containing a lancing device to a testing
device for testing analytes in bodily fluids comprising:

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a housing surface adapted to be removably mounted on the testing device; and
a projection on the housing surface,

wherein the projection is configured for connection with a housing feature on
the testing device, such that the connector connects the adapter to the testing device.

5

26. A connector according to claim 25, wherein the housing surface is a battery
door and the housing feature is an opening on the testing device.

27. A method of providing an integrated testing device, comprising:
10 providing a testing device for testing analytes in bodily fluids;

providing an adapter containing a housing, a lancet assembly, a test port for
holding a test strip, a strip connector for establishing electrical contact between a test
strip m the test port of the adapter and the testing device, and a housing connector for
connecting the adapter housing to the testing device; and
1 5 attaching said adapter to said testing device using the housing connector.

28. A method of sampling and testing a sample of bodily fluid comprising:
providing a testing device for testing analytes in bodily fluids;
providing an adapter containing a housing, a lancet assembly including a

20 lancet, a test port for holding a test strip, a test strip disposed in the test port, a strip
connector for establishing electrical contact between a test strip in the test port of the
adapter and the testing device, and a housing coimector for coimecting the adapter
housing to the testing device;

attaching the adapter to the testing device using the housing connector to form
25 an integrated device;

cocking the lancet assembly; and

actuating the lancet assembly to drive the lancet into the skin a predetermined
depth to produce a sample of bodily fluid, wherein the test strip absorbs the sample
and produces a signal indicative of an analyte level and wherein the strip connector ■
30 automatically transmits the signal indicative of the analyte level to the testiag device.

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PCT/GB02/03772

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PCT/GB02/03772

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PCT/GB02/03772

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PCT/GB02/03772

Fig. 9b

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PCT/GB02/03772